Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel nucleic acid-based therapeutics for
oncology and rare diseases, today reported its financial and
operational results for the second quarter ended June 30, 2016.
“The second quarter of this year represented a period of solid
execution throughout the organization,” stated Vincent Milano,
Idera’s Chief Executive Officer. “As a result of the efforts
of the team to continue driving our programs forward, we are
rapidly approaching critical data readouts for Idera. During
the second half of this year, we expect to be in position to share
important data from our melanoma trial with IMO-2125, as well as
the next steps in the program. We also expect to be in a
position to select a recommended Phase 2 dose for our B-cell
lymphoma program with IMO-8400. Lastly, we plan to begin
elucidating the path forward for the 3GA (third generation
antisense) platform, which we believe represents a pillar in the
foundation of the company we are building.”
Continued Milano, “I’m very proud of the team’s focus and
determination as they continued to advance our research and
development programs. We certainly have much more work ahead
of us to arrive at our ultimate goal of delivering solutions to
patients; however, we are energized knowing that we will soon be in
possession of critical information to further understand the
potential of these opportunities.”
Research and Development Program
UpdatesIMO-2125 and IMO-8400 are the Company’s lead
clinical development drug candidates. IMO-2125 is an
oligonucleotide-based agonist of Toll-like receptor (TLR) 9.
IMO-8400 is an oligonucleotide-based antagonist of TLRs 7, 8, and
9. The Company also announced during the fourth quarter of
2015, the first two development targets from its proprietary 3GA
Technology platform: NLRP3 (NOD-like receptor family, pyrin
domain containing protein 3) and DUX4 (Double Homeobox 4).
The Company continues to evaluate these and other potential targets
for clinical proof of concept. The Company plans to take the
first 3GA candidate into human proof of concept studies in
2017.
Toll-like Receptor (TLR) Agonism
Immuno-Oncology ProgramIdera’s development
program in immuno-oncology is based on the rationale that
intra-tumoral injections of IMO-2125, a TLR9 agonist, will activate
dendritic cells and modulate the tumor microenvironment to
potentiate the anti-tumor activity of checkpoint inhibitors.
This rationale is supported by pre-clinical data in multiple tumor
types. These studies have led Idera into a strategic
alliance with the University of Texas MD Anderson Cancer Center to
evaluate the combination of intra-tumoral IMO-2125 with checkpoint
inhibitors.
In December 2015, Idera announced the initiation of a Phase 1/2
clinical trial of intra-tumoral IMO-2125 in combination with
ipilimumab, a CTLA4 antibody being conducted at the University of
Texas MD Anderson Cancer Center. This study is in patients
with relapsed or refractory Metastatic Melanoma who have failed
prior PD-1 therapy. The trial continues to accrue patients
according to plan and the Company intends to present the first
clinical immune response translational data from this trial,
addressing the mechanism of action, during the second half of 2016
at a select immuno-oncology conference, with clinical results
expected in 2017.
The study has recently been amended to include the exploration
of the combination of IMO-2125 with pembrolizumab, an anti-PD1
antibody.
Toll-like Receptor (TLR) Antagonism
Genetically Defined Forms of B-cell Lymphoma
Idera’s program in genetically defined forms of B-cell lymphoma is
based on pre-clinical studies that have demonstrated that, in
certain B-cell lymphomas driven by the oncogenic MYD88-L265P
mutation, blocking TLR7 and 9 signaling can promote tumor cell
death.
In December 2015, Idera presented positive clinical data from
the ongoing Phase 1/2 trial of IMO-8400 in patients with
Waldenstrom’s Macroglobulinemia at the 57th Annual Meeting of the
American Society of Hematology (ASH) in Orlando, FL. The
Company is continuing dose escalation of IMO-8400 in the ongoing
trials in Waldenstrom’s Macroglobulinemia and Diffuse Large B-cell
Lymphoma to explore the full potential of IMO-8400 based on the
safety profile and efficacy signals seen to date. The Company
plans to be in position to select a recommended Phase 2 dose by
year end 2016.
Idera previously announced that the U.S. Food and Drug
Administration (FDA) granted orphan drug designation for IMO-8400
for the treatment of Waldenstrom’s macroglobulinemia and DLBCL.
Rare DiseasesIn November 2015, Idera announced
the initiation of a Phase 2 clinical trial of IMO-8400 in patients
with Dermatomyositis, a rare auto-immune condition, which
negatively affects skin and may result in debilitating muscle
weakness. TLRs have been reported to play a role in the
pathogenesis of the disease. This randomized, double-blind,
placebo controlled Phase 2 trial is expected to enroll 36 patients
and is being conducted at approximately 20 clinical sites
worldwide. The Company plans to complete enrollment of this
trial by the end of 2017.
Third Generation Antisense Platform
(3GA)Idera’s proprietary third-generation antisense (3GA)
platform technology is focused on silencing the mRNA associated
with disease causing genes. Idera has designed 3GA
oligonucleotides to overcome specific challenges associated with
earlier generation antisense technologies and RNAi
technologies.
In late 2015, Idera announced the identification of NLRP3
(NOD-like receptor family, pyrin domain containing protein 3) and
DUX4 (Double Homeobox 4) as initial gene targets to advance into
IND-enabling activities, which will occur throughout 2016.
Potential disease indications related to these targets include, but
are not limited to, interstitial cystitis, lupus nephritis, uveitis
and facioscapulohumeral muscular dystrophy (FSHD). The
Company is currently conducting clinical, regulatory and commercial
analysis activities and conducting IND-enabling studies with the
plan to enter the clinic in 2017 for the first clinical development
program. In addition to these activities, over the first half
of 2016, Idera generated 3GA compounds for a series of additional
gene targets. These will enable the Company to continue to
expand its future pipeline opportunities for both internal
development as well as partnerships in areas outside of Idera’s
focus. Idera plans to present pre-clinical data at several
conferences in the second half of 2016.
In late 2015, Idera entered into a collaboration and license
agreement with GSK to research, develop and commercialize compounds
from its 3GA technology for the treatment of undisclosed, selected
renal targets. As per the terms of the agreement, Idera
received an upfront payment of $2.5 million and is eligible to
receive up to approximately $100 million in milestone payments in
addition to royalties.
Financial Results
Second Quarter
2016 Results
Net loss for the three months ended June 30, 2016 was $13.5
million, or $0.11 per basic and diluted share, compared to a net
loss of $12.7 million, or $0.11 per basic and diluted share, for
the same period in 2015. Revenue totaled $0.3 million and $0.6
million during the three and six months ended June 30, 2016,
respectively. There was nominal revenue recognized during the
corresponding 2015 periods. For the six month period ended June 30,
2016, the Company’s net loss was $26.3 million, or $0.22 per basic
and diluted share, compared to a net loss of $25.2 million, or
$0.23 per diluted share, for the same period in 2015.
Research and development expenses for the three months ended
June 30, 2016 totaled $10.1 million compared to $9.0 million for
the same period in 2015. For the six month period ended June 30,
2016, research and development expenses totaled $19.4 million
compared to $17.7 million for the same period in 2015.
General and administrative expense for the three months ended
June 30, 2016 and June 30, 2015 totaled $3.8 million, respectively.
For the six month period ended June 30, 2016 and June 30, 2015,
general and administrative expenses totaled $7.7 million,
respectively.
As of June 30, 2016, Idera’s cash, cash equivalents and
investments totaled $64.1 million compared to $87.2 million as of
December 31, 2015. The company expects the current cash
position and investments to fund its operations into the third
quarter of 2017.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is a clinical-stage biopharmaceutical
company developing novel nucleic acid-based therapies for the
treatment of certain cancers and rare diseases. Idera’s proprietary
technology involves using a TLR-targeting technology, to design
synthetic oligonucleotide-based drug candidates to act by
modulating the activity of specific TLRs. In addition to its TLR
programs, Idera has created a third generation antisense technology
platform using its proprietary technology to inhibit the production
of disease-associated proteins by targeting RNA. To learn more
about Idera, visit www.iderapharma.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. All statements, other than statements of historical fact,
included or incorporated in this press release, including
statements regarding the Company's strategy, future operations,
collaborations, intellectual property, cash resources, financial
position, future revenues, projected costs, prospects, clinical
trials, plans, and objectives of management, are forward-looking
statements. The words "believes," "anticipates," "estimates,"
"plans," "expects," "intends," "may," "could," "should,"
"potential," "likely," "projects," "continue," "will," and "would"
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Idera cannot guarantee that it will
actually achieve the plans, intentions or expectations disclosed in
its forward-looking statements and you should not place undue
reliance on the Company's forward-looking statements. There are a
number of important factors that could cause Idera's actual results
to differ materially from those indicated or implied by its
forward-looking statements. Factors that may cause such a
difference include: whether results obtained in pre-clinical
studies and clinical trials such as the results described in this
release will be indicative of the results that will be generated in
future clinical trials; whether products based on Idera's
technology will advance into or through the clinical trial process
when anticipated or at all or warrant submission for regulatory
approval; whether such products will receive approval from the U.S.
Food and Drug Administration or equivalent foreign regulatory
agencies; whether, if the Company's products receive approval, they
will be successfully distributed and marketed; whether the
Company's collaborations will be successful; and such other
important factors as are set forth under the caption "Risk Factors"
in the Company’s Annual Report on Form 10-K and Quarterly Report on
Form 10-Q for the periods ended December 31, 2015, and June 30,
2016, respectively. Although Idera may elect to do so at some point
in the future, the Company does not assume any obligation to update
any forward-looking statements and it disclaims any intention or
obligation to update or revise any forward-looking statement,
whether as a result of new information, future events or
otherwise.
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Idera Pharmaceuticals,
Inc. Condensed Statements of Operations - Unaudited(In thousands,
except per share data) |
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Three Months
Ended |
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Six Months
Ended |
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June 30, |
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June 30, |
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2016 |
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2015 |
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2016 |
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2015 |
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Alliance Revenue |
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|
$ |
301 |
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$ |
5 |
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$ |
595 |
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$ |
39 |
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Operating Expenses |
|
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Research &
Development |
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10,128 |
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8,960 |
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19,424 |
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17,680 |
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General &
Administrative |
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3,778 |
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3,821 |
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7,694 |
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7,658 |
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Total Operating
Expenses |
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|
13,906 |
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|
12,781 |
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|
27,118 |
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|
25,338 |
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Loss from
Operations |
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|
|
(13,605 |
) |
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|
(12,776 |
) |
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|
(26,523 |
) |
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(25,299 |
) |
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Other Income (Expense),
Net |
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|
|
120 |
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|
57 |
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|
215 |
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|
99 |
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Net Loss |
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|
$ |
(13,485 |
) |
|
|
$ |
(12,719 |
) |
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|
$ |
(26,308 |
) |
|
|
$ |
(25,200 |
) |
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Basic and diluted net
loss per common share applicable to common stockholders |
|
|
$ |
(0.11 |
) |
|
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$ |
(0.11 |
) |
|
|
$ |
(0.22 |
) |
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|
$ |
(0.23 |
) |
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Shares used in
computing basic and diluted net loss per common share applicable to
common stockholders |
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|
121,323 |
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|
118,002 |
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|
121,304 |
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|
111,570 |
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Idera Pharmaceuticals,
Inc.Condensed Balance Sheet Data(In thousands) |
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At June
30, |
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At December
31, |
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2016 |
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2015 |
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(Unaudited) |
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Cash, Cash Equivalents
& Investments |
|
|
$ |
64,096 |
|
|
|
$ |
87,157 |
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Other Assets |
|
|
|
5,141 |
|
|
|
|
5,119 |
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Total Assets |
|
|
$ |
69,237 |
|
|
|
$ |
92,276 |
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Total Liabilities |
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|
$ |
8,188 |
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|
$ |
8,694 |
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Total Stockholders'
Equity |
|
|
|
61,049 |
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|
83,582 |
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Total Liabilities &
Stockholders' Equity |
|
|
$ |
69,237 |
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|
|
$ |
92,276 |
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Investor Contact:
Robert Doody
VP, IR & Corporate Communications.
617-679-5515 (office)
484-639-7235 (mobile)
rdoody@iderapharma.com
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